FSP Sr CRA I

Thermo Fisher Scientific • Denver, CO

5d

About The Position

As a Senior Clinical Research Associate I in the FSP model, you will be dedicated to one specific client and represent that client while collaborating with investigational sites and the project team. You will perform and coordinate clinical monitoring and site management, conducting remote and on-site visits to assess protocol and regulatory compliance and manage required documentation. You will help ensure trials follow the approved protocol, ICH-GCP guidelines, applicable regulations, and SOPs, protecting subjects’ rights and well-being and supporting reliable data. The role also focuses on audit readiness and collaborative relationships with investigational sites.

This position requires travel of more than 75% as needed for site monitoring. The stated work schedule is standard Monday through Friday, and the work environment is an office. The Colorado salary range is $90,000–$113,000, with possible eligibility for a variable annual bonus based on company, team, and/or individual performance.

Requirements

• Bachelor’s degree in a life sciences-related field, Registered Nursing certification, or equivalent relevant formal academic or vocational qualification.
• Previous experience providing the knowledge, skills, and abilities to perform the role, comparable to 3+ years.
• Strong critical-thinking and problem-solving skills.
• Excellent remote and on-site clinical trial monitoring skills.
• Demonstrated understanding of ICH-GCP guidelines, applicable regulations, and SOPs.
• Ability to work on problems of diverse scope, evaluate data and identifiable factors, and use sound judgment when selecting methods and techniques.
• Strong communication and collaboration skills, including effective interaction with investigative sites, clients, and internal teams.
• Ability to represent the client while maintaining professional relationships.
• Advanced written and oral communication skills.
• Strong organizational skills and attention to detail.
• Demonstrated ability to use computer systems, including CTMS and other trial management platforms.
• Ability to travel more than 75% as required for site monitoring activities.

Nice To Haves

• Oncology experience.

Responsibilities

• Monitor investigator sites using a risk-based monitoring approach.
• Use root cause analysis, critical thinking, and problem-solving to identify site process failures and corrective or preventive actions.
• Ensure data accuracy through source data review (SDR), source data verification (SDV), and case report form (CRF) review, as applicable, during on-site and remote monitoring.
• Assess investigational products through physical inventory and records review.
• Document observations in reports and letters promptly, using approved business writing standards.
• Escalate deficiencies and issues to clinical management and follow them through resolution.
• Maintain contact with investigative sites between monitoring visits to confirm protocol compliance, resolution of identified issues, and timely data recording.
• Conduct monitoring tasks according to the approved monitoring plan.
• Participate in the investigator payment process and share responsibility with project team members for resolving issues and findings.
• Provide trial status and progress updates to the Clinical Team Manager (CTM) as required.
• Update study systems, including the Clinical Trial Management System (CTMS), according to study conventions, and perform quality-control checks of CTMS reports when required.
• Participate in investigator meetings as necessary.
• Identify potential investigators with the client company and assess the acceptability of qualified investigative sites.
• Initiate clinical trial sites under applicable procedures and recommend actions as warranted to support protocol, regulatory, and ICH-GCP compliance.
• Ensure trial closeout and retrieval of trial materials.
• Ensure essential documents are complete and in place according to ICH-GCP and applicable regulations; conduct on-site file reviews as specified by the project.
• Contribute to the project team by assisting with preparation of project publications and tools and sharing ideas and suggestions.
• Perform additional study tasks assigned by the CTM, such as trip report review, newsletter creation, or leading CRA team calls.
• Facilitate communication among investigative sites, the client company, and the project team through written, oral, and electronic contacts.
• Respond to company, client, and applicable regulatory requirements, audits, and inspections.
• Complete administrative tasks, including expense reports and timesheets, promptly.
• Contribute to other project work and process-improvement initiatives as required.

Benefits

• Choice of national medical and dental plans and a national vision plan, including health incentive programs.
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement.
• At least 120 hours of paid time off (PTO) and 10 paid holidays annually.
• Paid parental leave, including 3 weeks for bonding and 8 weeks for caregiver leave.
• Accident and life insurance, and short- and long-term disability in accordance with company policy.
• Competitive 401(k) U.S. retirement savings plan.
• Employees’ Stock Purchase Plan (ESPP), with eligible colleagues able to purchase company stock at a discount.
• Possible eligibility for a variable annual bonus based on company, team, and/or individual performance results, in accordance with company policy.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior